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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 21, 2018 FBO #6146
DOCUMENT

66 -- V16 CPT CPRR BPA Automated FIT Testing - Justification and Approval (J&A)

Notice Date

9/19/2018
 

Notice Type

Justification and Approval (J&A)
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Chief, A&MM (90C/NLR);Central Arkansas Veterans HCS;2200 Fort Roots Drive, Bldg 41, Room 224;North Little Rock AR 72114 1706
 

Archive Date

10/4/2018
 

Point of Contact

Sheila D Reed
 

E-Mail Address

7-1053<br
 

Small Business Set-Aside

N/A
 

Award Number

VA256-15-A-0102
 

Award Date

9/4/2018
 

Description

OFOC SOP Revision 08 Page 2 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: Not Applicable Contracting Activity: Department of Veterans Affairs, South Central VA Network VISN wide BPA. Department of Veterans Affairs South Central VA Health Care Network (SCVAHCN) Central Arkansas Veterans Healthcare System Contracting Office (90C) North Little Rock, AR NCO 16 Nature and/or Description of the Action Being Processed: The proposed action by SCVAHCN is to exercise option year three (3) of VISN 16 BPA VA256-15-A-0102 with Polymedco, Inc. for continuation of VISN Cost per Patient Reportable Result (CPRR) and Cost per Test (CPT) pricing for specialized automated fecal immunochemical testing (FIT) instrumentation, repair, reagents and consumables for Medical Center Laboratories. The basis for the sole source award is Federal Acquisition Regulation (FAR) 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. Polymedco currently meets and satisfies the needs of these laboratories. Existing CPRR and CPT BPA pricing will continue for the option year. Exercising of the option will continue to secure price reductions and volume discounts for Medical Center and Outpatient Clinic laboratories for automated FIT instrumentation and testing. Also, it will allow laboratories to continue to provide automated testing for colorectal cancer screening and diagnosis of gastrointestinal (GI) bleeding. Description of Supplies/Services Required to Meet the Agency s Needs: Polymedco will continue to provide instrumentation, repair, reagents and consumables to each participating laboratory. Exercising of the option year (October 1, 2018 through September 30, 2019) will ensure the vendor continues to provide instrumentation and testing reagents and supplies as defined for CPRR/CPT programs. The exercising of the option year for VISN 16 laboratories will continue to provide standardized testing instrumentation for detecting the presence of blood in stool for colorectal cancer (CRC) screening and the detection of occult blood in stool utilizing automated FIT through-out the Network. It will also ensure the vendor continues to meet all licensing and accreditation requirements, permits, certifications required by the FDA and the Government. All provisions within the original BPA, including use of equipment (testing instrumentation, UPSs, etc), preventative maintenance, emergency repair, reagents, controls, calibration materials, and replacement parts, will continue. Statutory Authority Permitting Other than Full and Open Competition: ( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; Automated Fecal Immunochemical Testing (FIT) is required for VISN 16 laboratories for detecting the presence of human blood in stool for the purposes of colorectal cancer (CRC) screening and detection of gastrointestinal (GI) bleeds. FIT based testing for the presence of human blood in stool is recommended by the VHA National Center for Health Promotion and Disease Prevention for CRC as it is more sensitive and specific than guaiac based tests. Unlike guaiac based tests, FIT testing is also free of patient dietary restrictions, making it superior to that of guaiac based tests, for patient use and preparation. For those reasons VISN 16 laboratories chose to implement and standardize FIT testing for the detection of blood in stool samples back in 2009. Standardization to an automated method was also chosen as the analyzer offers walk-away testing and lab staff can perform other duties while the analyzer is performing patient testing. Upon completion of testing, the results are automatically sent to the VistA lab package for technologist review and release into the medical record. This functionality improves turn-around- times and also eliminates a patient safety risk that is associated with manual entry of patient test results into the record. Polymedco is the only vendor with Automated Fecal Immunochemical Testing Instrumentation and reagents. Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Polymedco has successfully provided specialized automated FIT instrumentation, repair, reagents and consumables to Medical Center Laboratories. The highly-specialized instrumentation includes automated fecal immunochemical testing (FIT) pre-assembled personal collection packs. The packs include Colorectal Cancer (CRC) Screening collection vials, patient sample collection instructions, and mailers for return of patient samples. The mailers are pre-addressed and metered for each medical center. Testing instrumentation is interfaced to the VistA laboratory package eliminating the need to manually input patient test results. Polymedco is the only vendor that manufacturers and provides automated FIT testing. The need to continue to provide these laboratory tests to veterans is critical. Without exercising the option year, the laboratories will not have equipment or reagents available for the performance of these automated cancer screening tests required for patient care. VISN 16 solicited and awarded BPA VA256-15-A-0102 using Far 8.405-3 procedures to Polymedco, Inc. against their FSS (Federal Supply Schedule) contract V797P-7136A in 2015. On March 31, 2018, their FSS contract expired with no extension or new contract in place. Polymedco has submitted the packet to the National Acquisition Center (NAC) for award of a new FSS contract; however, all reviews have not been completed. It is necessary to proceed with exercising the option year of the BPA to prevent significant delays in care for our Veterans and increased costs to the Government. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Polymedco is currently the only vendor with automated fecal immunochemical testing instrumentation and reagents. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Polymedco instrumentation and reagents are already in use at each VISN 16 Medical Center. Polymedco will continue to provide use of equipment, service and repair, reagents and consumables at previous BPA CPRR. CPRR/CPT BPA pricing is discounted when compared to FSS pricing. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: On-line of FSS/GSA schedule holders for SIN 605-2b did not provide any vendors capable of offering automated fecal immunochemical instrumentation service/repair, interfacing and reagents. Review of Vendor Information Pages (VIP) NAICS 334516, FSC group 6630 and SIN 605-2b identified 3 vendors; Diamond Systems, LLC, Emergency Planning Management, Inc and Global Vacuum, LLC. None of those vendors manufacture or provided automated fecal immunochemical instrumentation, service/repair, interfacing and reagents. Any Other Facts Supporting the Use of Other than Full and Open Competition: None known. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. ALL APPROVAL SIGNATURES REMOVED (SDR)
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/5b2c5aefa41bb4312fd979c957766a60)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA256-15-A-0102 P00004 VA256-15-A-0102 P00004.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4600402&FileName=VA256-15-A-0102-P00004000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4600402&FileName=VA256-15-A-0102-P00004000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN05095845-W 20180921/180919230854-5b2c5aefa41bb4312fd979c957766a60 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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